N/A
N=45
A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses
Astigmatism Bilateral
Bottom Line
View on ClinicalTrials.gov: NCT03684928 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Ease of Insertion(Handling) — 9.1; 9.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Comfilcon A (test) (Device); Senofilcon C (control) (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ease of Insertion(Handling) |
8.8; 8.5 | — |
| PRIMARY Ease of Insertion (Handling) |
8.9; 8.5 | — |
| PRIMARY Ease of Insertion(Handling) |
8.8; 8.5 | — |
| SECONDARY Rotational Recovery After Lens Mislocation |
26; 23; 23; 18 | — |
| SECONDARY Rotational Recovery After Lens Mislocation |
26; 23; 23; 18 | — |
Summary
The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has had a self-reported oculo-visual examination in the last two years.
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
- Is willing to wear contact lens in both eyes for the duration of the study;
- Has a minimum astigmatism of - 0.75, determined by refraction;
- Can be fit with the two study contact lens types in the powers available;
- Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
- Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
- Has clear corneas and no active* ocular disease;
Exclusion Criteria
A person will be excluded from the study if he/she:
- Is participating in any concurrent clinical trial;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study measure;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
- Has known sensitivity to fluorescein dye or products to be used in the study;
- Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery;
- Has participated in the previous QUENA study.
Data sourced from ClinicalTrials.gov (NCT03684928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.